(1) Field of the Invention
The present invention relates to agents and to methods for affecting metabolic function and in particular to a conductive coating, film, or covering on a body tissue to distribute electrical charge, either passively or in conjunction with applied electrical energy.
(2) Prior Art
The electrophysiological nature of neural transmission is well known. However, certain evidence suggests that there are electrophysiological mechanisms functioning at the level of entire organs or tissues. For example, acupuncture, which appears to have at least an electrophysiological component, has been recognized by the National Institutes of Health as effective in treating a variety of disorders (NIH Consensus Statement, Acupuncture, National Institutes of Health, 15, 1-34, 1997) and must work on a scale much larger than that which has been rigorously studied at the cellular level. In this field, metal needles are introduced through the skin into the deeper tissues, and manipulated either manually or electrically or both. By this means, various effects on physiology are produced. For example, acupuncture has been shown to produce anesthesia, reduce nausea, ameliorate dysmenorrhea, and lessen the symptoms of asthma, most of which effects are produced at considerable distance from the point of needle insertion. That this is purely an electrophysiological effect is not clear, as the acupuncture literature imputes the effects to a bodily energy known as chi; additionally, certain procedures have been shown to produce effects within the central nervous system (see, e.g., Neurobiology of Acupuncture, Ma, S., eCAM, 1:1 41-47, 2004). However, as was concluded in the NIH Consensus Statement, it is clear that needling does affect body functions and that the body's tissues have varying levels of conductivity and electrical charge.
In manipulating the needles, the acupuncturist is said to transfer his or her own chi to the patient, and it is thought by some that this transfer is actually a flow of electrical energy (Electrophysiology and the Acupuncture Systems, Starwynn, D., Medical Acupuncture, 13:1, 2006). In addition to manually manipulated needles, electrical stimulation of acupuncture points has been used extensively. Some of the means of stimulation have used electrodes rather than needles (see, for example, U.S. Pat. No. 6,691,622). This patent relates to the use of electrically conductive means. This patent suggests that increasing the ability of charge to disperse at the various acupuncture points on the body may increase the efficacy of acupuncture techniques.
It has been demonstrated that the body generates endogenous electric fields in response to wounding (see, for example, Electrical signals control wound healing through phosphatidylinositol-3-OH kinase-γ and PTEN, Zhao, M. et al, Nature 442, 457-460, 2006). That such fields exist in the body, and that manipulation of them by externally applied electrical energy can affect the rate of healing, argues strongly that electrophysiological effects at a macroscopic level play an important role in regulating metabolic function.
Another bit of evidence from folk medicine is the reported use of a bar of soap to relieve nocturnal leg-muscle cramps. Since it is reportedly not necessary for the soap to touch the skin in order to be effective, it is hard to see by what possible mechanism such an effect might be mediated until it is recognized that ionic surfactants, a major component of most commercial soaps, are very effective at dispersing static electrical charge. The dispersion of surface charge has not been shown previously to have any effect on cramping or any other metabolic condition, but in the absence of any other plausible physical mechanism for this effect it does suggest a possible electrophysiological mechanism operating at a larger scale than has been widely appreciated until recently.
Techniques exist that include conductive means attached to the skin, such as electrodes, to monitor electrochemical events within the body (see, for example, U.S. Pat. No. 6,434,410). Electrolytic gels and solutions provide a conductive interface between the skin and external devices. These devices are constructed to interact minimally with the electric fields of the body, being rather means for measuring or monitoring such electric fields.
Other known techniques relate to the use of conductive means in alleviating muscular pain and other conditions. U.S. Pat. No. 5,944,740, for example, relates to the use of what is essentially a flat battery attached to the surface of the skin to cause electric current to flow through the skin and into the deeper tissues. This is a small, discrete device that generates an active voltage differential to achieve its effect. It is specifically configured to deliver electrical energy from an external source via discrete and limited electrode shapes using electrodes of alternating polarity in close proximity to each other. It is also relatively large in cross section, making it conspicuous in everyday use.
U.S. Pat. No. 4,398,545 relates to the use of a self-adhesive bandage with a flexible, electrically conductive inner surface coupled to an electrical stimulation unit to block pain via TENS. This technology is well known in the open medical literature, but briefly involves pulses of electrical energy applied to the patient's skin in order to create low current pulses and magnetic fields within the patient's body which block neural pain transmission. This and other such devices, including electrodes used specifically in electrically stimulating acupuncture points, see U.S. Pat. No. 6,691,622, are configured to deliver electrical energy from external sources via discrete and limited electrode shapes using electrodes of alternating polarity in close proximity to each other. They, too, have a substantial cross-sectional area and are obtrusive in everyday use.
U.S. Pat. No. 5,785,040 relates to the use of a highly-conductive gel on the surface of the skin, coupled to an electrode, to provide a means of either applying electrical energy to the body or to monitor electrical fields within the body. It uses a clear, disposable gel means that is easily positioned and removed from the body in conjunction with a washable, permanent electrode means for connection to the appropriate medical devices. This is intended for use with such systems as those contemplated or supported in U.S. Pat. Nos. 4,398,545, 6,434,410, and 6,691,622. Also, the applied gel must be made thick enough for easy manipulation, and so would be conspicuous and awkward to secure in place in everyday use.
U.S. Pat. No. 3,911,910 relates to the use of electrodes attached to the body to relieve spasticity in limbs by sensing spastic contractions and applying current pulses to cause the antagonistic muscles to contract. This does not directly relieve cramping or spasm, but rather overcomes the contraction by stimulating the opposing muscles to stretch out the affected muscle. In addition, its electrode means are discrete, limited in size, and must be carefully positioned to properly contract the only those muscles opposing the cramped muscle.